Chronic obstructive pulmonary disease (COPD) is the most common comorbidity among patients being treated for any type of cancer with an immune checkpoint inhibitor in the medical oncology clinic. There is a critical need to measure the treatment burden of COPD and design a scalable intervention to optimize its care. Our primary aim is to determine the ideal design of a care pathway to optimize COPD in community oncology clinics. This mixed-methods study will collect data to quantify and understand the disease burdens, components of care, and barriers in the medical oncology clinic. As per user-centered design methodology, participants at design team workshops will then integrate these data into a COPD care pathway. This study will provide critical data on the impact of COPD upon patients with cancer and identify how its care can be optimized in the medical oncology clinic. These results will directly inform a novel care pathway that will be designed for scalability in the community setting. Future studies will test this pathway versus usual care in a cluster randomized controlled trial across a network of oncology clinics.Clinical Trial Registration: ClinicalTrials.gov NCT05984680.
Keywords: Chronic obstructive pulmonary disease (COPD); care pathway; comorbidity; immunotherapy; implementation science; lung; outcomes research; supportive care.
This clinical trial protocol will design a care pathway for chronic obstructive pulmonary disease (COPD) among patients who are receiving immunotherapy for cancer. COPD is a common and often underdiagnosed comorbidity in cancer patients, particularly those receiving immune checkpoint inhibitors (ICIs). These patients face significant challenges as COPD can worsen their overall health, impact the effectiveness of their cancer treatment, and increase the risk of severe side effects like pneumonitis. The study will use a mix of qualitative and quantitative methods to collect data on the burdens and barriers associated with COPD care in oncology clinics. This dataset will be used to develop a “user-centered” care pathway that is tailored specifically for patients who are dealing with both cancer and COPD. The study involves surveys, interviews, and guided tours to gather insights from patients, oncology providers, and COPD specialists. The goal is to create a feasible and scalable care pathway that can be implemented in community oncology clinics, where most patients are treated. This pathway aims to reduce the treatment burden on patients, improve their quality of life, and ensure that COPD is managed effectively alongside their cancer treatment. The study also explores the potential barriers to implementing this care pathway and seeks to find practical solutions to overcome them. This study has the potential to inform the design of future clinical trials and improve care for patients with both COPD and cancer. The findings will also contribute to the broader understanding of how to manage comorbidities in cancer care.